Study of Anlotinib in Patients With Small Cell Lung Cancer (ALTER1202)

CTTQ

Status and phase

Completed

Phase 2

Conditions

Small Cell Lung Cancer

Treatments

Drug: Anlotinib

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03059797

ALTN-12-II

Details and patient eligibility

About

To compare the effects and safety of Anlotinib with placebo in patients with small cell lung cancer(SCLC).

Enrollment

120 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histological documentation of small cell lung cancer
Advanced small cell lung cancer who had at least two chemotherapy regimens,at least one measurable lesion (by RECIST1.1)
18-75 years,ECOG PS:0-2,Life expectancy of more than 3 months
Main organs function is normal
Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
Patients should participate in the study voluntarily and sign informed consent

Exclusion criteria

Patients who have been used anlotinib
Patients who have been used targeted drugs(such as sunitinib,bevacizumab,endostar),Immune targeted drugs
4 weeks or less from the last cytotoxic therapy, radiation therapy or surgery
Patients whose primary lesion with active bleeding within 4 months
Carcinomatous meningitis
Patients who known to the central nervous system
Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
Patients with any severe and/or unable to control diseases，including：
1. Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);
2. Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc≥450ms(male),QTc≥470ms（female）) and patients with Grade 1 or higher congestive heart failure (NYHA Classification);
3. Patients with active or unable to control serious infections;
4. Patients with cirrhosis, decompensated liver disease, or active hepatitis;
5. Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L)
6. Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed;
Patients with non-healing wounds or fractures
Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism
Patients with drug abuse history and unable to get rid of or Patients with mental disorders
Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage
History of immunodeficiency
Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment